Athersys, a small drug maker in Cleveland, Ohio, is using the story of a stroke survivor to promote the development of an experimental stem cell therapy. But by doing so, the company has obscured the treatment’s clinical trial failure.
The story of the stroke survivor, an Oregon woman named Sharon Thomas, is heartwarming. It’s been widely told and promoted through an ongoing, Athersys-funded publicity campaign. Thomas appears alongside Athersys CEO Gil Van Bokkelen in a video in which she explains how, after suffering a massive stroke that left her unable to walk, speak, or swallow, she received the company’s experimental stem cell therapy called MultiStem. Eight days later, she walked out of the hospital, not fully healed but on her way.
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Well, I can only agree that anecdotal patient stories are a very dubious if not despicable strategy to promote any medication.
I think the reanalysis of the failed phase 2B needs to be seen a little more in a neurology and stroke specific manner. The gating factor for any treatment of stroke is time from stroke onset to intervention. It is therefore perfectly reasonable to analyse a subgroup that is defined by time to intervention. A treatment that shows improved results with more prompt intervention is in line with everything else that has ever been seen in stroke ( thrombectomy, blood pressure control and tPA being the obvious candidates). It is therefore very reasonable to assume that a treatment that has been shown to work in a time to intervention based subgroup will work in an adequately designed follow-on study. It seems that the FDA agrees in allowing both an identical study but for the time limit to intervention to proceed as well as granting an SPA. I assume a treatment that increases the time window for stroke treatment from 4.5h and 6h to 36h is huge news indeed, if it can show any real effect, time will tell!